Kornimate/medical-research-clean huggingface dataset:
efficacy of tbct, mbhp and ppt for ptsd during the covid-19 pandemics

Conditions: Posttraumatic Stress Disorder; Covid19

Summary: the psychotherapies to be assessed in the present study, delivered on-line, are: trial-based cognitive therapy (tbct), mindfulness-based health promotion (mbhp), and positive psychotherapy (ppt). objectives: 1) to assess the efficacy of tbct compared to mbhp and ppt in reducing the symptoms of ptsd during the covid-19 pandemic.

background: research has suggested the use of different forms of psychotherapy to decrease drop-out rates in the post-traumatic stress disorder (ptsd) treatment. the psychotherapies to be assessed in the present study are: trial-based cognitive therapy (tbct), mindfulness-based health promotion (mbhp) and positive psychotherapy (ppt). objectives: our objectives are: 1) to assess the efficacy of tbct compared to mbhp and ppt to reduce the symptoms of ptsd in the context of the covid-19 pandemic, all delivered online; 2) to compare the efficacy of these psychotherapies in reducing symptoms of anxiety and depression, and in improving well-being; 3) to describe how patients and professionals perceive teletherapy. methods: this is a three-arm, randomized, multicenter, single-blind, clinical trial. an estimated sample of 135 patients will receive either tbct, mbhp or ppt, individual, weekly visits, totaling thirteen sessions. the primary outcome measure will be the caps-5, and the secondary outcome measures will be the hospital anxiety and depression scale (hads), the negative core beliefs inventory (ncbi), and the trauma-related guilt inventory (trgi). other measures are the who-5 well-being index (who-5), and the california psychotherapy alliance scale (calpas-p). also, questions about patients perception of teletherapy will be asked. expected results: ptsd symptoms are expected to be reduced after tbct, mbhp and ppt. the null hypothesis is that no statistical difference is expected to be found among the three psychotherapies, as opposed to the alternative hypothesis that tbct and mbhp are superior to ppt.

Eligibility criteria:
inclusion criteria: * both sexes; * aged 18 to 60 years; * scoring 45 or more on the pcl-5 * ptsd developed (or aggravated by) as a result of direct or indirect exposure to covid-19 \[e.g., health professionals, people who tested positive for covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves\]; * participants should be able to read, write and follow instructions, and have access to the a stable internet connexion. exclusion criteria: * severe suicide risk (plans, attitudes or suicide attemps for the last 12 months); * self-mutilation behavior (for the last 12 months); * already in psychotherapy; * psychotic symptoms; * current substance abuse or addiction (last 12 months).

Keywords: cognitive-behavior therapy trial-based cognitive therapy mindfulness based health promotion positive psychotherapy ptsd covid 19 randomized clinical trial
efficacy and safety of vb119 in subjects with membranous nephropathy

Conditions: Membranous Nephropathy

Summary: this study is a phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, pk, and pd of vb119 in subjects with primary mn


Eligibility criteria:
inclusion criteria: 1. is ≥ 18 years of age at the time of informed consent; 2. has a kidney biopsy-proven diagnosis of primary mn within the past 10 years; note: it is preferable that subjects enrolled have kidney biopsy tissue samples that are positive for anti-pla2r antibody staining. subjects with kidney biopsy-proven diagnosis of primary mn \>10 years and ≤20 years that meet all other eligibility criteria may be enrolled after discussion with the medical monitor. 3. 3. has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g upcr by spot collection) and has proteinuria with a upcr greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the screening period. both samples must qualify; 4. has systolic blood pressure (bp) \<160 mmhg or diastolic bp \<100 mmhg after 5 minutes of rest at screening; 5. is willing and able to provide written informed consent prior to screening; 6. female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the screening visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at screening, based on the central laboratory's ranges; 7. female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days after the last administration of study drug. 8. male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug. exclusion criteria: 1. has an egfr \<45 ml/min/1.73 m2 at screening utilizing the chronic kidney disease epidemiology collaboration formula confirmed by the central laboratory; 2. has an absolute neutrophil count \<1.5 x 10/l; 3. has a white blood cell count \<3.0 x 10/l; 4. has secondary causes of mn (eg, malignancy, hepatitis b or c, human immunodeficiency virus \[hiv\], systemic lupus erythematosus \[sle\], or other autoimmune diseases \[eg, thyroiditis\], drug-induced); 5. has a diagnosis or history of sle (including non renal disease); 6. has type 1 or 2 diabetes mellitus; 7. has an acute, chronic, or latent infection, including tuberculosis, hepatitis, hiv, or chronic urinary tract infections;
a study with cit-013 in ra patients

Conditions: Rheumatoid Arthritis

Summary: the goal of this clinical trial is to learn if cit-013 works to treat rheumatoid arthritis in adults. it will also learn about the safety of cit-013. the main questions it aims to answer are: does cit-013 lower the disease activity of ra patients? what medical problems do participants have when receiving cit-013? researchers will compare cit-013 to a placebo (a look-alike substance that contains no drug) to see if cit-013 works to treat the symptoms of ra. participants will: take receive cit-013 or placebo every other week for 12 weeks visit the clinic once every 2 weeks for checkups and tests keep monitor their symptoms during this period


Eligibility criteria:
inclusion criteria: * male or female patients with ra according to the 2010 classification criteria of the american college of rheumatology (acr) and the european league against rheumatism (eular) ≥ 3 months prior to screening * aged 18-85 * das28-crp ≥ 3.2, with ≥ 2 swollen joints, and ≥ 2 tender joints, and crp ≥ uln at screening and confirmed prior to randomization * at history of at least 3 months treatment and ≥ 4 weeks stable on a conventional synthetic disease modifying antirheumatic drug (csdmard) exclusion criteria: * contra-indication for cit-013 * current inflammatory joint disease other than ra (sjogren with active disease is included). * the washout period for bdmard or jaki prior to the first dose of investigational product should be at least: 1. ≥ 1 week for etanercept; 2. ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; 3. ≥ 6 months year for rituximab; 4. ≥ 2 weeks for tsdmard (either investigational or commercially available treatment). * treated with ≥ 3 bdmard or tsdmard * injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
erils und snils unter soc

Conditions: Stroke, Acute

Summary: 1. how many erils occur in caucasian patients with laa stroke during 7 days on standard treatment? 2. how many snils occur between 7 and 30 days after acute ischemic event on standard treatment? 3. how many of during acute event diagnosed lesions (erils) are (still) detectable after 30 days? 4. are there relevant risk faktors for the occurence of erils and snils (eg diabetes or biomarkers)?

in this trial, patients will be observed if they develop early recurrent ischemic lesions (= erils) or silent neurologic ischemic lesions (= snils) after acute stroke or transitoric ischemic attack (tia) based on atherothrombosis (laa-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via dw-mri (diffusion-weighted magnetic resonance imaging). we want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies

Eligibility criteria:
inclusion criteria: * laa stroke or tia * erils or snils detected in initialdw-mri * signed informed consent exclusion criteria: * planned surgical intervention * iv thrombolysis * atrial fibrillation * contra indications against dw-mri
cardiovascular effects of salvia miltiorrhiza extract (danshen)

Conditions: Dyslipidemias; Hypertension; Vasodilation; Oxidative Stress; Inflammation

Summary: rationale: extracts of the plant salvia miltiorrhiza (danshen) have been used as traditional chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and myocardial infarction. several preclinical studies point towards promising effects of danshen on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and hypertension. objective: our primary objective is to determine the effect of salvia miltiorrhiza extract (danshen) on hyperlipidemia. secondary objective is to investigate the effect of danshen on hypertension. further objectives are to determine its effect on endothelial function, oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.


Eligibility criteria:
inclusion criteria: * age: 40-70 * women: * postmenopausal, or * use of contraceptive pill * hyperlipidemia: * elevated level of triglycerides: \> 1.7 mmol/l, or * elevated level of ldl-cholesterol: \> 3.5 mmol/l * hypertension: * systolic pressure \> 140 mm hg, or * diastolic pressure \> 90 mm hg * signed informed consent exclusion criteria: * alcohol or drug abuse * history of cardiovascular disease (myocard infarct, angina pectoris, cva) * diabetes mellitus, when treated with insulin * pregnancy * hyperlipidemia which needs conventional treatment * elevated level of triglycerides: \> 8 mmol/l * elevated level of ldl-cholesterol: \> 5 mmol/l * hypertension which needs conventional treatment: * systolic pressure \> 180 mm hg * diastolic pressure \> 110 mm hg * clinically significant liver disease (3 times the upper normal limit of alat,asat) * clinically significant anemia (male hb \< 6,9 mmol/l, female \< 6,25 mmol/l) * renal disease defined as mdrd \< 60 ml/min/1.73m2 * participation to any drug-investigation during the previous 90 days * use of any herbal product during the previous 30 days * concomitant (chronic) use of: medicinal products: * ace-inhibitors, including a.o. captopril, enalapril, ramipril * at1-antagonists, including a.o. losartan, valsartan, irbesartan * statins, including a.o. simvastatin, rosuvastatin * anticoagulant drugs, including a.o. aspirin * calciumantagonists (including a.o. amlodipine, nifedipine, verapamil) * use of more than 1 antihypertensive drug * high-dose antihypertensive medication (above defined daily dose) * drugs which are exclusively metabolised by cyp3a4 (flockhart da; p450 drug interaction table, including a.o. erythromycin, midazolam, cyclosporine, hiv antivirals) food products: * (antioxidant) vitamin supplements * other herbs, including a.o. st john's wort * grapefruit juice

Keywords: hyperlipidemia hypertension vasodilation oxidative stress inflammation hemostasis hemorheology cardiovascular diseases cardiovascular agents salvia miltiorrhiza danshen danshen root extract molecular mechanisms of pharmacological action therapeutic uses
epidemiological study of korean radiation workers

Conditions: Occupational Exposure to Radiation; Neoplasms, Radiation-Induced; Leukemia, Radiation-Induced; Radiation Effects

Summary: health risks of radiation exposure in the moderate-to-high dose range have been well established. however, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. the purpose of this study is to construct a cohort of korean radiation workers and to assess health effects associated with occupational radiation exposure. the study population is expected to be about 190,000 korean radiation workers who have been registered with the nuclear safety and security commission since 1984. the national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data are collected based on the nuclear safety act. through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases.

the study population of this study is approximately 190000 korean radiation workers registered with the nuclear safety and security commission since 1984. diagnostic medical radiation workers were not included in the study population. the national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data for radiation workers are collected retrospectively or prospectively based on the nuclear safety act. through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases. this data collection will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers if possible. age- and sex-specific standardized incidence and mortality ratios will be calculated for overall comparisons of cancer and non-cancer disease risks with general population. for dose-response assessment, excess relative risk (per gy) and excess absolute risk (per gy) will be estimated with adjustments for age and potential confounders, such as lifestyle factors and socioeconomic status.

Eligibility criteria:
inclusion criteria: * korean radiation workers in the national dose registry (except for diagnostic medical radiation workers) exclusion criteria: * unidentified personal identification numbers * foreigner

Keywords: ionizing radiation cohort study radiation workers radiation-induced diseases
ultrasound guided percutaneous cholecystostomy.

Conditions: Gall Bladder Disease

Summary: surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease

the etiology of biliary obstruction can be benign or malignant. benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients \[5\], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children \[6\]. obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children \[7\]. biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients \[8\]. the question remains as to whether all patients undergoing pct drainage require a definitive cholecystectomy. previous publications have suggested that there is a reluctance to use pct in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.

Eligibility criteria:
inclusion criteria: * pyocele of the gallbladder * mucocele of the gallbladder * perforated gallbladder * malignant causes of gallbladder obstruction exclusion criteria: * uncontrolled bleeding disorders
a pilot study of amygdala retraining program in patients with chronic fatigue syndrome, chronic fatigue and fibromyalgia

Conditions: Chronic Fatigue Syndrome; Chronic Fatigue; Fibromyalgia

Summary: the purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the amygdala retraining program (arp), a mind-body practice versus a control (c) on fatigue, quality of life and sleep in patients with chronic fatigue syndrome (cfs), chronic fatigue (cf) and fibromyalgia (fm). cfs, cf and fm are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (fukuda 1994). current literature points to a centrally sensitized state in cfs, cf and fm (meeus 2007). the arp attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. a case series of 33 patients with cfs and arp reported improvement in 92% of patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (gupta 2009). however arp has never been formally studied in cfs. we propose to gather preliminary data on the efficacy and feasibility of arp versus c on fatigue, quality of life and sleep in 30 patients with cfs, cf and fm. all participants will undergo standard clinical treatment which consist of a 2 day self-management program in the chronic fatigue clinic. following this, participants will be randomized into the arp or c group. the arp group will receive an additional 2.5 hour training surrounding core concepts of the arp program. they will then be given the arp dvd program and booklet, to reinforce and continue the practice. they will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support. the c group will receive only standard care. however they will receive a complementary copy of the arp program at the end of the study (6 month time point) as a gift for participation in the study. preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: multidimensional fatigue inventory (mdfi), short form-36 (sf36) fibromyalgia impact questionnaire (fiq), epworth sleep scale (ess) and measure your medical outcome profile (mymop-2). feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of arp and any specific difficulties they encountered in the practice of the program.


Eligibility criteria:
inclusion criteria: * meet cdc criteria for chronic fatigue syndrome, have been diagnosed with chronic fatigue, or meet the american college of rheumatology criteria for fibromyalgia exclusion criteria: * untreated hypo or hyper thyroidism * untreated hypo or hyper parathyroidism * untreated adrenal disorders * untreated diabetes * multiple sclerosis * acute or chronic hepatitis * history of cancer * untreated depression * chronic steroid use * acute inflammatory rheumatological conditions * untreated obstructive sleep apnea * narcolepsy
erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma

Conditions: Recurrent or Refractory Pediatric Ependymoma

Summary: this is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

this is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.

Eligibility criteria:
inclusion criteria: * recurrent of refractory ependymoma or subependymoma * performance status (ps): lansky ≥ 50% for patients ≤ 10 years of age or karnofsky ≥ 50% for patients \>10 years of age * measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks * recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy * ≥ 1 year to ≤ 21 years * serum creatinine for patients ≤ 5 years in age is ≤ 0.8 mg/dl or creatinine clearance/glomerular filtration rate (gfr) ≥ 70 ml/min/m\^2 * serum creatinine for patients \> 5 and ≤ 10 years in age is ≤ 1.0 mg/dl or creatinine clearance/gfr ≥ 70 ml/min/m\^2 * serum creatinine for patients \> 10 and ≤ 15 years in age is ≤ 1.2 mg/dl or creatinine clearance/gfr ≥ 70 ml/min/m\^2 * serum creatinine for patients \> 15 years in age is ≤ 1.5 mg/dl or creatinine clearance/gfr ≥ 70 ml/min/m\^2 * total bilirubin is ≤ 1.5 x upper limit of normal for age * alanine aminotransferase (alt) ≤ 3 x upper limit of normal * absolute neutrophil count \> 1000/µl * platelet count \> 100,000/µl * hemoglobin \> 8 gm/dl * neurologically stable for at least 7 days prior to randomization * if receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization * patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug exclusion criteria: * previously received epidermal growth factor receptor (egfr)-targeted therapy * previously received oral etoposide * received craniospinal radiotherapy within 24 weeks prior to randomization * received field radiotherapy to the target lesion within 12 weeks prior to randomization * received symptomatic metastatic disease within 14 days prior to randomization * received myelosuppressive chemotherapy within 21 days before randomization * received growth factors within 7 days prior to randomization * participating in another investigational drug trial * received a biologic agent within 7 days prior to randomization * received a monoclonal antibody within 28 days prior to randomization * taking cytochrome p450 (cyp)3a4 or cyp1a2 inhibitors/inducers within 14 days prior to randomization * taking proton pump inhibitors within 14 days prior to randomization * smoking during treatment * pregnant or breast-feeding females

Keywords: pediatric etoposide erlotinib phase 2 ependymoma
ischemic strokes while on noac - how compliance matters

Conditions: Stroke, Ischemic; Stroke, Acute; Stroke Syndrome; Stroke, Cardiovascular; Atherosclerosis; Ischemic Stroke

Summary: this study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of is-noac in face of the rapidly increasing noac usage. knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of is-noac.

data will be retrieved from the stroke registry of prince of wales hospital which recorded all in- and out-patients with stroke or transient ischaemic attack (tia). all consecutive adult patients with known af who developed ischaemic stroke or tia in 2010, 2012, 2014, 2016 and 2018 (i.e. 5 full yearly time-points) and categorize the patients according to their anticoagulation status (elaborated below) with the inclusion and exclusion criteria stated will be recruited. all demographic data, blood results, imaging and assessment data will be retrieved from electronic patient record (cms system) and stroke registry. all-cause mortality at 1 year will be verified via cms system too.

Eligibility criteria:
inclusion criteria: 1. patients who were ethnic chinese 2. patients with known af 3. patient who suffered from ischaemic stroke exclusion criteria: 1. patient who are non-ethnic chinese 2. patient who suffered from haemorrhagic stroke

Keywords: stroke, noac